Can Our Aging Cold Chain Infrastructure Handle the Boom in “Living Drugs”?

The pharmaceutical and medical sector supply chains have always handled some of the most delicate and environmentally sensitive products. Some medicines require intense cold to make it to their destinations while maintaining their efficacy. Cell and gene therapy cold chain logistics have rapidly developed due to strong market interest. However, it is debatable whether or not it is keeping a reasonable pace. What does the industry look like right now, and what can it do to keep moving forward?

The Current State of the Sector

Cell and gene therapies (CGTs) are contentious. Because of public uncertainty, legislation regulating these products has been infrequent and stalled, as has investment and innovation. Meanwhile, conventional pharmaceutical manufacturing has become deeply ingrained in society, creating the supply chain infrastructure that underpins modern medicine. Rewriting this would be labor-intensive and expensive. 

However, global medicine is quietly advancing to a market driven by personalization. Every prescription and treatment plan must be designed with the individual and their biomarkers in mind, making CGTs the future of health care. This will make recoveries more likely to succeed.

Unfortunately, the expensive, controversial creation and transportation of these products mean cold chain logistics have failed to receive advancements. An oncologist’s survey discovered 47% of people did not understand CGTs at all. If the public is unfamiliar with a lifesaving technology, why would they fund or advocate for the systems that support it, such as cold chain equipment and logistics refinement?

This hints at the root of the problem and why the pace of cold chain improvements is not matching up with the suddenly booming interest. The CGT market will be worth $93.78 billion by 2030, but its preservation technologies need dedicated attention for these investments to be worthwhile. Only then will the FDA find it valuable to approve more of these products per year.

The Demanding Nature of CGT Logistics

Traditional medicines are easier to handle than the high demands of CGTs. They can be packaged in bulk and stored over a wider temperature range. They are easily manufactured in large quantities, making them high-value while remaining affordable. 

Meanwhile, CGTs have a long list of requirements with few short-term benefits for makers to reap. They must be produced in small batches, with some orders being patient-specific. This makes them valuable only to one customer, while being exorbitantly expensive to produce. Its shelf life is a fraction of conventional medicines, making shipping more logistically demanding and high-risk.

However, one of its most important supply chain nuances is CGT’s need for cryogenic temperatures. Specialized freezers are required for a CGT’s success. They have unique peripherals like compressors for pressurization and heat exchangers, which must preserve the chain of identity for autologous medicines. 

Temperatures range. Some medicines only need to be kept between 2° and 8° degrees Celsius, while others at cryogenic temperatures need to be at -160° to -180° degrees C.

The last mile of delivery is often the most volatile yet crucial part of the transportation process. Every time the freezer is moved from place to place, it introduces potential compromises to the equipment and the climate. Preventing these situations is a challenge, especially across a potentially global supply chain. Even though a medicine could travel thousands of miles, a mistake in the last mile could cost significantly. Supply chain upsets lead to a potential 38% loss for medical tech companies. 

How Aging Cold Chain Infrastructure Fails CGT’s Future

There is already minimal cryogenic infrastructure, with known shortages being one of the foremost barriers to CGT scalability. What does exist is failing, causing thousands of samples to be lost and ruining decades of work. 

While some cold storage equipment features modern amenities such as real-time analytics and remote monitoring, this is not always the case. Legacy systems lack these modern features, making them difficult to attune to the needs of even more complex, personalized medicines. This could make temperature excursions more common, with employees potentially unaware that they have occurred.

It is also possible that, as these mechanisms become more outdated, fewer people will be trained to operate them. The Covid-19 pandemic catalyzed interest in people, but it is still a challenging industry to hire for. This means hospitals and manufacturers alike would be less interested in investing in cold chain logistics because they know finding people to oversee them will be an expensive and time-consuming process. 

Additionally, the medical sector is already known for its siloed infrastructure, and incorporating old and new cold chain logistics and novel research about CGT could make it even more fragmented. A combination of antiquated and modern systems could make it hard for facilities and manufacturers to communicate about these sensitive products as they go from place to place. This heightens the risk of error and miscommunication. 

Ways to Address These Gaps

Cell and gene therapy cold chain logistics can have a promising future if stakeholders advocate for the same developments in the sector. The collaboration will demonstrate the industry’s priorities and needs to legitimize and scale CGT worldwide. These should be at the forefront:

• Public and private investments in modern cryogenic infrastructure.
• Adoption of modern data-driven technologies for oversight.
• Retrofits and middleware options for existing cold storage equipment.
• End-to-end supply chain communications and technological interoperability.
• Specialized training and upskilling for the workforce.

With these goals, managers in these sectors have a chance to align the advancement of cold chain tech with the growing interest in CGTs as a whole. Eventually, the two topics will become inextricably linked in the public eye, aligning their developments for sensible pharmaceutical progression.

How Cell and Gene Therapy Cold Chain Logistics Advances

CGT has a promising outlook, but it rests on the development of more robust regulations and technologies in cold chain storage and supply chain management. It will not matter how well-crafted the medicine is and its potential rate of success for a specific illness if it cannot reach its patient. To keep CGT thriving and transform its public perception, it must survive every step of the logistics and supply chain process.